GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL

GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL is an FDA 510(k)-cleared medical device (K032168) manufactured by W. L. Gore & Associates, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 14, 2003. Regulation: 8.